Standardization request approved for standards to support regulations for medical devices

Green light for standards to be harmonised for medical devices regulations

The European Regulations for medical devices (MDR), 2017/745, and in vitro diagnostic medical devices (IVDR), 2017/746, have specific roles for harmonised European standards. Article 8 in each regulation indicates that harmonised standards are those referenced in the Official Journal of the European Union. Devices in conformity with relevant harmonised standards, or applicable parts of standards, are presumed to be in conformity with the requirements of the regulation covered by those standards. Additionally, the presumption of conformity also applies to system or process requirements, including those requirements relating to quality management systems and risk management. European standards that are intended to be harmonised include a European Foreword and Annex Zs that describe the relationship between the requirements of the standard and the regulatory requirements in the European regulations that are applicable to the scope of that standard.

A Standardization Request from the European Commission to the European Standards Organisations , CEN and CENELEC, provides the legal basis for harmonising standards. Agreement of this request allows publication of references to harmonised standards that provide a presumption of conformity under the MDR and IVDR to start. On 12 May 2021, the European Standards Organisations , CEN and CENELEC, formally accepted the Standardization Request from the European Commission for standards to support the MDR and IVDR. This initiates steps to revise or develop more than 200 harmonised standards for medical devices.

A previous Standardization Request had been rejected by CEN and CENELEC because of several concerns over the limited list of standards identified in the request together with requirements in the request related to:

• the scope of harmonised European standards being restricted only to legal requirements of the MDR and IVDR; and,
•  consistency of definitions in harmonised European standards with those in the European legislation.

The European Commission made amendments to the request and added clarification that:

• the request is not a static document, but it will be the starting point for systematic updates when necessary for lists of standardisation items and deadlines for the adoption. These updates will be carried out on a regular basis, approximately at six-month intervals, according to the specific situation;
• new standards may be added to the initial work programme provided the EC has been consulted and agrees to that addition; and,
• if definitions differ from those in regulations , the differences need to be indicated in the European Annex Z s. In such cases, it needs to be indicated that, for use in support of European requirements, definitions in the European regulations for medical devices take precedence.

Acceptance of the standardization request will start the process to amend or revise many standards for devices. Standards that are harmonised for the directives for medical devices will not automatically to added to the lists of standards supporting the Regulations. In some cases, a European amendment to change the European Foreword and replace the Annex Zs for the directives with annexes showing the relationship between the standard and the MDR and IVDR, as applicable, will be required. In other cases, an ongoing amendment or revision of the standard can be used to update the Foreword and Annex Zs. There is a common deadline of 27 May 2024 for all the requested standards to be in place.

The European Commission has indicated that the first lists of harmonised standards for the MDR and IVDR should be ready by June 2021, shortly after the Date Of Application of the MDR. Candidates for this first list of standards will come from those standards that have been published with agreed European Foreword and Annex Z for the MDR or IVDR. The lists of standards will be updated and enlarged periodically.

Manufacturers using standards to support conformity with the MDR and IVDR, should be aware of the acceptance of the standardization request and watch out for publication of the first list of harmonised standards for the regulations for medical devices.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development